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FLUOCIM

DESCRIPTION

Fluocim (fluoxetine) is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), some eating disorders, and panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks). Fluoxetine is used to relieve the symptoms of premenstrual dysphoric disorder, including mood swings, irritability, bloating, and breast tenderness. Fluoxetine is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

HOW TO USE THIS MEDICATION

Fluocim comes as a capsule (20mg) to take by mouth usually as once a day in the morning or twice a day, in the morning and at noon. Fluoxetine may be taken with or without food. To help you remember to take fluoxetine, take it around the same time every day. Follow the directions on your leaflet label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of fluoxetine and gradually increase your dose.

It may take 4 to 5 weeks or longer before you feel the full benefit of fluoxetine. Continue to take Fluocim even if you feel well. Do not stop taking Fluocim without talking to your doctor. Your doctor will probably decrease your dose gradually.

PRECAUTIONS I SHOULD CONSIDER DURING THERAPY

         Inform your doctor and pharmacist if you are allergic to fluoxetine or any other medications.

         do not take fluoxetine if you are taking monoamine oxidase (MAO) inhibitors, including phenelzine (Nardil) and tranylcypromine (Parnate), or have stopped taking them within the past 2 weeks. Do not take fluoxetine with thioridazine (Mellaril).

         Inform your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: alprazolam (Xanax); anticoagulants ('blood thinners') such as warfarin (Coumadin); antidepressants (mood elevators) such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin), and naproxen (Aleve, Naprosyn); diazepam (Valium); digoxin (Lanoxin); flecainide (Tambocor); insulin or oral medications for diabetes; lithium (Eskalith, Lithobid); medications for anxiety and Parkinson's disease; medications for mental illness such as clozapine (Clozaril), haloperidol (Haldol), and pimozide (Orap); medications for seizures such as carbamazepine (Tegretol) and phenytoin (Dilantin); sedatives; sleeping pills; sumatriptan (Imitrex); tranquilizers; tryptophan; and vinblastine (Velban). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

         Inform your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), or mania (frenzied, abnormally excited mood), or if you or anyone in your family has thought about or attempted suicide. Also tell your doctor if you have recently had a heart attack and if you have or have ever had diabetes, seizures, or liver or heart disease.

         Inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking fluoxetine, call your doctor.

         you should know that fluoxetine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

         remember that alcohol can add to the drowsiness caused by this medication.

         you should know that your mental health may change in unexpected ways, especially at the beginning of your treatment and at any time your dose is increased or decreased. These changes may occur at any time if you have depression or other mental illness, whether or not you are taking fluoxetine or any other medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling or staying asleep; irritability; aggressive behavior; acting without thinking; severe restlessness; and frenzied, abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor when you are unable to seek treatment on your own.

WHAT TO DO IF I FORGET A DOSE

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

UNDESIRABLE SIDE EFFECTS

Frequently: drowsiness, headache, nervousness, sleep disturbances, shaking, anxiety, dizziness, profuse sweating, nausea, dry mouth, diarrhea, impaired appetite, a slight loss of weight, gastric disturbances.

Occasionally: unusual dreams, epileptic disorders, vomiting, shivering, blurred vision, GI disturbance (constipation, vomiting, feeling of fullness), breathing difficulties, tiredness, decreased libido, skin rashes, hypersensitivity reactions

Seldom: agitation states, hallucinations, confusion, psychosis, sensitivity to sun light, hair loss, prolonged erection, disturbance of menstruation, breast enlargement, cardiac arrhythmias, difficulties in swallowing, in isolated cases disturbances of involuntary movements.

During treatment with Fluocim alcohol should be avoided

It is necessary to adjust the dose of insulin and/or oral anti-diabetic tablets during the treatment with Fluocim in diabetics.


OVER DOSAGE

         The most common signs and symptoms associated with non-fatal over-dosage were seizures, somnolence, nausea, tachycardia, and vomiting.

         Other important adverse events reported with fluoxetine overdose (single or multiple drugs) include coma, delirium, ECG abnormalities (such as QT interval prolongation and ventricular tachycardia, including torsades de pointes-type arrhythmias), hypotension, mania, neuroleptic malignant syndrome-like events, pyrexia, stupor, and syncope.

STORAGE CONDITIONS

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

MANUFACTURER

SIEGFRIED and marketed by CIMEX SWITZERLAND

TO download leaflet click PAGE ONE & PAGE TWO


 
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